Pediatric Clinical Trial
Official title:
SECOND GENERATION COLON CAPSULE ENDOSCOPY (CCE-2) IN PEDIATRIC CROHN'S DISEASE (CD).
Verified date | July 2014 |
Source | Azienda Policlinico Umberto I |
Contact | n/a |
Is FDA regulated | No |
Health authority | Italy: Ethics Committee |
Study type | Interventional |
This prospective pilot study of 40 pediatric patients with Crohn's Disease, that are
candidates for endoscopic and imaging re-evaluation, examines the Given Diagnostic System
and the second generation of colon capsule in comparison second generation of colon capsule
endoscopy (CCE-2) to magnetic resonance enterography (MRE), small intestine contrast
ultrasonography (SICUS) and endoscopy (upper and lower).
This study aims
1. To evaluate and compare the accuracy of CCE-2 with MRE, SICUS and endoscopy in the
evaluation of pediatric Crohn's disease.
2. To evaluate the safety of CCE-2 in pediatric CD.
Status | Completed |
Enrollment | 40 |
Est. completion date | July 2014 |
Est. primary completion date | January 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 6 Years to 18 Years |
Eligibility |
Ages Eligible for Study: 6-18 Years Genders Eligible for Study: Both Accepts Healthy
Volunteers: No Inclusion criteria: Subjects must meet one the following inclusion criteria to be eligible for enrollment into this proposed study: - diagnosis of Crohn's Disease made at least 3 months before the enrolment; - subject was referred for endoscopic and imaging follow-up in Crohn's Disease - signed informed consent. Exclusion criteria The presence of any of the following will exclude a subject from study enrollment: - Subject has dysphagia - Subject has renal insufficiency - Subject is known structuring Crohn's Disease identified by magnetic resonance enterography (MRE) or small intestine contrast ultrasonography (SICUS). - Subject has had prior abdominal surgery of the gastrointestinal tract other than uncomplicated procedures that would be unlikely to lead to bowel obstruction based on the magnetic resonance enterography findings and clinical judgment of the investigator. |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
Italy | Pediatric Gastroenterology and Liver Unit, Sapienza - University of Rome | Rome |
Lead Sponsor | Collaborator |
---|---|
Azienda Policlinico Umberto I |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To evaluate and compare the accuracy of Second generation of Colon Capsule Endoscopy with magnetic resonance enterography, small intestine contrast ultrasonography and endoscopy in the evaluation of pediatric Crohn's disease. | Accuracy parameters (sensitivity, specificity, NPV, PPV) of second generation of colon capsule endoscopy compared to endoscopy, to magnetic resonance enterography and to small intestine contrast ultrasonography in evaluating disease activity in pediatric CD. The disease activity will be evaluated with a validated score (SES-CD) for endoscopy and imaging tool (damage-score). |
3 days | No |
Secondary | To evaluate the safety of second generation of colon capsule endoscopy in pediatric Crohn's disease. | Number, type and severity of adverse events with second generation of Crohn's disease. | two days | Yes |
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